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November 02, 2017
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
October 31, 2017
FDA announced a public workshop to explore strategies for addressing the crisis of opioid addiction through innovations in packaging, storage, and disposal.
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
October 27, 2017
The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.
October 25, 2017
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
Scott Gottlieb, MD, went before the House Committee on Energy and Commerce to give members the agency’s view on how to fight the opioid crisis, stressing the use of long-term treatment with drug therapy.
The M&A advisory firm has developed an interactive map of manufacturing sites to give insight into the market size of global manufacturing.
October 24, 2017
The agency has published educational material for physicians promoting the benefits of biosimilars.
October 20, 2017
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.